When conducting a vulnerability assessment under the FSMA Intentional Adulteration (IA) rule, one of the most commonly misunderstood distinctions is the difference between inherent characteristics and mitigation strategies.

Let’s break down what each term means and why the distinction matters when developing food defense plans that align with the IA rule requirements.

what are inherent characteristics?

FDA’s IA rule guidance describes inherent characteristics as, “conditions, activities, procedures, or characteristics that are integral to the operation of a point, step, or procedure; the point, step, or procedure could not properly operate without these inherent characteristics in place.”

Put another way, they are naturally present features of a process step and are not easily altered or changed.

When we were developing the IA rule at FDA, one of our goals was to allow companies to “count” inherent characteristics during the vulnerability assessment process. The idea was to reduce unnecessary burden by recognizing that some steps already have a lower vulnerability by their very nature—due to the equipment used, product form, or process conditions.

But that only works if companies understand and correctly apply the distinction. Misunderstanding this can lead to over- or under-identifying APSs, which affects both compliance and efficiency.

Examples of inherent characteristics include:

• Entirely enclosed and/or pressurized equipment
• Nature of the food being processed (solid vs. liquid)
• A step where food is moving at a high rate of speed
• A step where there is little to no mixing of the product
• A step where multiple workers must be present for the process to function

If you are using a vulnerability assessment method that directly evaluates Elements 1, 2, and 3 (i.e., any method other than the Key Activity Types approach alone), inherent characteristics can, and should be considered, especially when scoring Elements 2 and 3. Their presence tends to lower the overall score, often resulting in fewer actionable process steps (APSs).

So, remember: inherent characteristics are considered during the vulnerability assessment —they help to reduce vulnerability scores before mitigation strategies come into play.

what are mitigation strategies?

The IA rule defines mitigation strategies as “those risk-based, reasonably appropriate measures that a person knowledgeable about food defense would employ to significantly minimize or prevent significant vulnerabilities identified at actionable process steps…”.

In plain terms, mitigation strategies are actions you apply after the vulnerability assessment, and only to those process steps identified as APSs.

These mitigation strategies must be:

• Customized to the specific actionable process step
• Facility-specific, based on layout, procedures, and operations
• Focused on the vulnerability at the actionable process step, including the actions of an inside attacker
• Supported by food defense management components: monitoring, corrective action, verification, and recordkeeping

why this distinction matters

Understanding the difference helps you use your resources effectively and avoid compliance issues.

• Overusing mitigation strategies? That could be the result of not factoring in inherent characteristics during the vulnerability assessment, resulting in over-identifying APSs. You may be compliant, but you’re likely spending more time and money than necessary.
• Skipping required mitigation strategies? That can happen when existing practices are wrongly treated as if they are inherent characteristics. This leads to under-identifying APSs, which puts your plan out of compliance with the IA rule.

bottom line

• Inherent characteristics are identified and considered during the vulnerability assessment—they help determine whether a step is significantly vulnerable.
• Mitigation strategies are identified and implemented after APSs have been determined—these are the actions you must apply to those steps in order to demonstrate the significant vulnerability is under control.

Understanding and applying this distinction correctly is key to building a compliant, efficient food defense plan.

Jon Woody led FDA’s food defense program for two decades and now consults on FSMA compliance and food defense strategies through his firm, Woody Food Strategies.

Originally posted on WoodyFoodStrategies.com. To inquire about reposting or reprinting, please contact info@woodyfoodstrategies.com.